Defining and Documenting Record Retention

M

MakingADifference

Involved In Discussions
#1
#1
Hi All.

With a view variations around for document retention times, I was wondered how everyone documented this in their control of records (or similar) procedures. Is there a one size fits all verbiage that we could apply.

Europe
MDR – Article 10
7. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market.

ISO 13485:2016
4.2.4 Control of documents
The organization shall define the period for which at least one copy of obsolete documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.5), or as specified by applicable regulatory requirements.

4.2.5 Control of records
The organization shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization.

FDA
21 CFR 820.180:

(b) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Ajit Basrur

Ajit Basrur

Staff member
Admin
#2
#2
As highlighted in the ISO 13485, it is up to the organization to define the retention period. FDA has prescribed a minimum but the organization could define the additional period above it.
 
I

indubioush

Quite Involved in Discussions
#4
#4
I am used to having a records control procedure with a matrix listing document and record type and the minimum retention time for each. The minimum retention time needs to match or exceed the retention time required by applicable regulations.
 
Q

QualityDean

Registered
#6
#6
MakingADifference said:
Hi All.

With a view variations around for document retention times, I was wondered how everyone documented this in their control of records (or similar) procedures. Is there a one size fits all verbiage that we could apply.

Europe
MDR – Article 10
7. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market.

ISO 13485:2016
4.2.4 Control of documents
The organization shall define the period for which at least one copy of obsolete documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.5), or as specified by applicable regulatory requirements.

4.2.5 Control of records
The organization shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization.

FDA
21 CFR 820.180:

(b) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
Click to expand...
Hey, I just want to thank you for the FDA information! I'm working on revising our Document and Records Control procedure and Retention Matrix. You answered my question perfectly! I love Elsmar! :)
 
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